ModifiedHealth NetPolicy CP PMN.238

Carbidopa/Levodopa ER Capsules (Crexont, Rytary), Enteral Suspension (Duopa), IR Tablets (Dhivy), Foscarbidopa/Foslevodopa (Vyalev) clinical policy

Clinical policy governing medical necessity, prior authorization, dosing limits, and coverage criteria for extended‑release and enteral carbidopa/levodopa products (Crexont, Rytary, Duopa, Dhivy) and foscarbidopa/foslevodopa (Vyalev) for members of Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyCarbidopa/Levodopa ER Capsules (Crexont, Rytary), Enteral Suspension (Duopa), IR Tablets (Dhivy), Foscarbidopa/Foslevodopa (Vyalev)

Policy CodePolicy CP PMN.238

Change TypeAdded products and coding updates

Effective DateSep 1, 2020

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results, or other clinical information) demonstrating the member meets all approval criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added newly approved products Crexont and Vyalev to the policy.

Added HCPCS code J7356 for Vyalev (foscarbidopa/foslevodopa).

Revised references and product-specific prescribing information updated through 2024–2025.

5drug products addressed

12 moapproval duration

18+minimum age

Dose limits

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Coverage and Medical Necessity Criteria

Initial therapy — Crexont or Rytary

Covered when ALL of the following are met for Crexont or Rytary (initial approval):

Crexont/Rytary initial: 1. Diagnosis of Parkinson disease or parkinsonism; 2. Request is for Crexont or Rytary; 3. Age > 18 years; 4. Documented intolerance or contraindication to carbidopa-levodopa sustained release tablets (Sinemet CR) that would not apply to Crexont or Rytary (examples include inability to swallow); 5. Dose does not exceed product-specific maximums (Crexont: carbidopa 525 mg/levodopa 2,100 mg per day OR Rytary: carbidopa 612.5 mg/levodopa 2,450 mg per day).

Initial therapy — Duopa or Vyalev

Covered when ALL of the following are met for Duopa or Vyalev (initial approval):

Duopa/Vyalev initial: 1. Diagnosis of Parkinson disease; 2. Request is for Duopa or Vyalev; 3. Prescribed by or in consultation with a neurologist; 4. Demonstrated clear responsiveness to levodopa; 5. For Duopa: motor fluctuations of 3 hours or more of 'off' time per waking day; for Vyalev: motor fluctuations of 2 hours or more of 'off' time per waking day; 6. Failure of at least two anti-Parkinson agents from different therapeutic classes (e.g., MAO-B inhibitor, COMT inhibitor, dopamine agonist) unless contraindicated or clinically significant adverse effects are experienced; 7. For Duopa requests, placement of a procedurally-placed tube has been completed or is planned; 8. Dose does not exceed product-specific maximums (Duopa: levodopa 2,000 mg/day cassette; Vyalev: foslevodopa 3,525 mg/day).

Initial therapy — Dhivy

Covered when ALL of the following are met for Dhivy (initial approval):

Dhivy initial: 1. Diagnosis of Parkinson disease or parkinsonism; 2. Request is for Dhivy; 3. Age > 18 years; 4. Dose does not exceed carbidopa 200 mg/levodopa 800 mg per day; 5. Member must use generic carbidopa-levodopa unless contraindicated or clinically significant adverse effects are experienced.

Continuation criteria

Continued therapy covered when ALL of the following are met:

Continued therapy: 1. Member is currently receiving the medication via the Centene benefit or has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. Continuity of care provisions apply when the member is enrolled in a state/product with such regulations.

Infusion therapy (Duopa, Vyalev) initiation

Covered when ALL of the following are met for infusion therapies (Duopa, Vyalev):

Infusion initiation criteria: 1. Conversion of the patient to oral immediate-release carbidopa-levodopa followed by calculation and administration of starting infusion doses (morning/loading dose and base continuous dose) per product prescribing information; 2. Documentation of calculation of total levodopa dosage (TLD) and conversion calculations when initiating Vyalev (TLD x 1.3 to determine total daily foslevodopa mg, divide by 240 to determine total daily volume in mL) and infusion rate determination; 3. For Duopa, initiation in the three-step process described in product prescribing information (conversion to oral IR, calculation of starting Duopa morning and continuous doses, and titration) and documentation of planned or completed PEG-J tube placement where applicable; 4. Titration plan and monitoring documented and dose adjustments made based on individual clinical response and tolerability; 5. Dose does not exceed product-specific maximums (Duopa: levodopa 2,000 mg/day administered over 16 hours; Vyalev: foslevodopa 3,525 mg/day).per product prescribing information

Duopa initiated in 3 steps; Vyalev conversion uses TLD x 1.3 and volume/infusion rate calculations

Product maximum dosing

Coverage limited when dosing exceeds product maximums:

Maximum dose limits: Duopa: maximum 2,000 mg levodopa per day (administered over a 16-hour infusion); Vyalev: maximum 3,525 mg foslevodopa per day; Rytary: maximum levodopa 2,450 mg per day; Crexont: maximum carbidopa 525 mg/levodopa 2,100 mg per day; Dhivy: maximum carbidopa 200 mg/levodopa 800 mg per day.explicit product maximums

Exceeding these product-specific maximums may be considered outside recommended dosing and not covered

Use of these medications for non‑FDA approved indications that are not specifically addressed in this policy is not covered unless the provider submits sufficient clinical documentation demonstrating efficacy and safety per the applicable off‑label use policies (for commercial: CP.CPA.09; health insurance marketplace: HIM.PA.154; Medicaid: CP.PMN.53).

Concomitant use of any product in this policy with a nonselective MAO inhibitor (for example, phenelzine or tranylcypromine), or use of a nonselective MAOI within the prior 2 weeks, is a contraindication and is not permitted.

Known hypersensitivity to any component of Dhivy is a contraindication to use of that product and must be documented; Dhivy should not be used in members with such hypersensitivity.

A history of failure of carbidopa‑levodopa sustained‑release tablets (Sinemet CR) alone is explicitly not an acceptable rationale to switch a member to Crexont or Rytary. The policy requires documented, clinically appropriate reasons (for example, inability to swallow or other contraindications) for use of the requested extended‑release product.

Any codes listed in this policy are provided for informational purposes only. Inclusion or exclusion of codes does not guarantee coverage; coding alone does not establish medical necessity. Providers must follow current professional coding guidance when submitting claims.

Coding and Dosing Reference

Coding — general notemixed

N/A	No explicit CPT/HCPCS/ICD codes listed in this part of the document.

HCPCS CodesHCPCS

J7356

Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg (Vyalev)

Vyalev dosing conversion multiplier

Volume calculationDivide the total daily foslevodopa dosage (mg) by 240 to determine total daily infusion volume (mL).

Duopa maximum daily levodopa

Maximum daily levodopa (Duopa)Maximum recommended daily Duopa levodopa component = 2,000 mg administered over a 16-hour infusion period (one cassette per day).

Administration periodDuopa is infused over a 16-hour daily period with patients disconnected at end of infusion and given nighttime oral immediate-release carbidopa-levodopa as needed.

Extra dose functionDuopa has an extra dose function (start at 1 mL = 20 mg levodopa) adjustable in 0.2 mL increments; limited to one extra dose every 2 hours.

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Failure to submit required supporting clinical documentation may result in denial of the request.

Applicable to requests for Duopa and Vyalev
Include documentation of diagnosis, neurologist involvement, levodopa responsiveness, and prior medication trials as applicable

Documentation Required

Infusion Therapy Documentation

For infusion therapies (Duopa and Vyalev), submit detailed infusion documentation with the prior authorization request. This includes the procedural plan or confirmation of PEG-J/tube placement for Duopa, titration and daily infusion parameters, the calculated total levodopa dosage (TLD) and Vyalev dosing calculations (including multiplier to determine foslevodopa component and total daily volume), and pump settings (hours infused, hourly rate, and extra-dose settings if used). For Duopa also document the planned or completed 16-hour infusion regimen and that the daily levodopa component does not exceed 2,000 mg. For Vyalev document that the foslevodopa component does not exceed 3,525 mg per day.

Clinical Background

Carbidopa/levodopa combinations and foscarbidopa/foslevodopa provide levodopa replacement for members with Parkinson disease and related parkinsonisms. Enteral suspension (Duopa) and the foscarbidopa/foslevodopa combination (Vyalev) are FDA‑approved specifically for the treatment of motor fluctuations in advanced Parkinson disease. These therapies differ by formulation and route of administration but share the goal of restoring dopaminergic activity to reduce “off” time and improve motor control.

Key Definitions

Foscarbidopa/foslevodopa (Vyalev)

DefinitionFoscarbidopa/foslevodopa (Vyalev) is a prodrug combination converted in vivo to carbidopa and levodopa; indicated for motor fluctuations in advanced Parkinson disease.

Therapeutic roleUsed to replace levodopa-containing medications for treatment of motor fluctuations in advanced PD and requires conversion calculations from TLD to foslevodopa dosing.

TLD (total levodopa dosage)

DefinitionTLD (total levodopa dosage) = total daily equivalent dosage of immediate-release levodopa for all levodopa-containing medications the patient is replacing.

Use in conversionTLD is converted to Vyalev foslevodopa dose by multiplying by 1.3 to obtain total daily foslevodopa (mg).

Basis for infusion calculations